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NCT03433378
To Evaluate the Therapeutic Equivalence and Safety of TRETINOIN CREAM, 0.05% and RLD in the Treatment of Acne Vulgaris
EARLY_PHASE1 trial testing Tretinoin cream, 0.05% in Acne Vulgaris in 700 participants. Completed in 26 January 2018.
26 January 2018
Quick facts
| Lead sponsor | Sun Pharmaceutical Industries, Inc. |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 700 |
| Start date | 4 August 2017 |
| Primary completion | 26 January 2018 |
| Estimated completion | 26 January 2018 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Tretinoin cream, 0.05%
- RETIN-A® (tretinoin) cream, 0.05% — full drug profile →
- Vehicle of the test product — full drug profile →
Conditions studied
- Acne Vulgaris — all drugs for Acne Vulgaris →
Sponsor
Sun Pharmaceutical Industries, Inc. — full company profile →
Who can join
Adults 12 to 40, any sex, with Acne Vulgaris. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Bioequivalence study comparing Tretinoin Cream, 0.05% to RETIN-A®.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03433378
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Acne Vulgaris
Currently open trials in the same condition.
- NCT07341087 — Skin Inflammation in Perimenopause: A Probiotic Intervention Proof of Concept Trial · NA · recruiting
- NCT07474883 — Efficacy of 0.5% Topical Timolol Eye Drops in the Treatment of Post-Inflammatory Erythema Following Acne Vulgaris · EARLY_PHASE1 · recruiting
- NCT07186413 — A Study to Compare the Efficacy, Safety and Pharmacokinetics of Trifarotene 50 mcg/g Cream in Chinese Subjects With Acne · Phase 3 · recruiting
- NCT07056673 — Cold Atmospheric Plasma for Moderate-to-severe Acne Vulgaris Study · NA · recruiting
- NCT07102186 — Efficacy and Safety of Adapalene Gel and Hyaluronic Acid Versus Adapalene Gel Alone in Mild to Moderate Acne Vulgaris · Phase 4 · recruiting
Other Sun Pharmaceutical Industries, Inc. trials
Trials by the same sponsor.
- NCT07469228 — A Study Comparing Tretinoin Gel Microsphere, 0.04% and RETIN-A MICRO ® Gel Microsphere, 0.04% in the Treatment of Acne V · Phase 1 · completed
- NCT06733402 — A Study Comparing Trifarotene Cream 0.005% to AKLIEF® CREAM (US REFERENCE LISTED DRUG), AKLIEF™ CREAM (CANADIAN REFERENC · Phase 1 · completed
- NCT06673641 — A Study Comparing Clindamycin Phosphate, Adapalene, and Benzoyl Peroxide Topical Gel 0.15%;3.1%;1.2% (Taro Pharmaceutica · Phase 1 · completed
- NCT06305637 — A Study Comparing Ketoconazole Shampoo, 2% and Ketoconazole 2% Shampoo (RS) in the Treatment of Tinea Versicolor. · Phase 1 · completed
- NCT06673654 — A Study, Comparing Ruxolitinib Topical Cream 1.5% (Taro Pharmaceuticals U.S.A, Inc.) to OPZELURA (Ruxolitinib) Cream for · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03433378 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sun Pharmaceutical Industries, Inc.
- Last refreshed: 18 May 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03433378.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing